title: A pharmacoeconomic modeling approach to estimate a value-based price for new oncology drugs in Europe.
abstract: BACKGROUND
  Several European governments have recently mandated price cuts in drugs to reduce health care spending. However, such measures without supportive evidence may compromise patient care because manufacturers may withdraw current products or not launch new agents. A value-based pricing scheme may be a better approach for determining a fair drug price and may be a medium for negotiations between the key stakeholders. To demonstrate this approach, pharmacoeconomic (PE) modeling was used from the Spanish health care system perspective to estimate a value-based price for bevacizumab, a drug that provides a 1.4-month survival benefit to patients with metastatic colorectal cancer (mCRC). The threshold used for economic value was three times the Spanish per capita GDP, as recommended by the World Health Organization (WHO).
  
  
  METHODS
  A PE model was developed to simulate outcomes in mCRC patients receiving chemotherapy ± bevacizumab. Clinical data were obtained from randomized trials and costs from a Spanish hospital. Utility estimates were determined by interviewing 24 Spanish oncology nurses and pharmacists. A price per dose of bevacizumab was then estimated using a target threshold of € 78,300 per quality-adjusted life year gained, which is three times the Spanish per capita GDP.
  
  
  RESULTS
  For a 1.4-month survival benefit, a price of € 342 per dose would be considered cost effective from the Spanish public health care perspective. The price may be increased to € 733 or € 843 per dose if the drug were able to improve patient quality of life or enhance survival from 1.4 to 3 months.
  
  
  CONCLUSIONS
  This study demonstrated that a value-based pricing approach using PE modeling and the WHO criteria for economic value is feasible and perhaps a better alternative to government mandated price cuts. The former approach would be a good starting point for opening dialog between European government payers and the pharmaceutical industry.
authors.affiliation: Department of Pharmacy, Nelson Mandela Metropolitan University, Port Elizabeth, South Africa. gdranit@ca.inter.net
authors.forename: George
authors.initials: G
authors.lastname: Dranitsaris
authors.forename: Ana
authors.initials: A
authors.lastname: Ortega
authors.forename: Martie S
authors.initials: MS
authors.lastname: Lubbe
authors.forename: Ilse
authors.initials: I
authors.lastname: Truter
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000191:economics* / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000191:economics* / Q000627:therapeutic use; D000068258:Bevacizumab; D015179:Colorectal Neoplasms / Q000188:drug therapy / Q000191:economics; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D004345:Drug Industry / Q000191:economics; D017850:Economics, Pharmaceutical; D005060:Europe; D059066:Gross Domestic Product; D006801:Humans; D018803:Models, Economic; D009362:Neoplasm Metastasis; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D016032:Randomized Controlled Trials as Topic; D013030:Spain; D016019:Survival Analysis
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000068258:Bevacizumab